MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL HD EPSCP,1.9,0,60,CW_STORZ; RIGID ENDOSCOPE

Catalog Number	242047
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the device was received at the supplier and evaluated.The reported complaint was confirmed.The following things were found during the evaluation.Outer tube damaged, needle.Outer tube bent.Outer tube compressed.Outer tube damaged, distal tip.Distal tip damaged.Optical system, optical components.Broken lenses in optical system.The possible root cause for the reported failures is user mishandling, however given the information provided we cannot determine a definitive root cause for the reported failures.A manufacturing record evaluation was performed for the finished device (serial: (b)(4)) number, and no non-conformances were identified.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.(b)(4).
Event or Problem Description
It was reported by an employee via phone that while inspecting returns, two of the hd arthroscope/sinuscope were bent where the lens comes out.The employee stated that one is bent at a ninety degree angle.The employee did not know how these devices became bent.There was no case involved, therefore no patient involvement or delay.The devices are being returned.

• Brand Name: HD EPSCP,1.9,0,60,CW_STORZ
• Common Device Name: RIGID ENDOSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8724375
• Report Number: 1221934-2019-57402
• Device Sequence Number: 13954234
• Product Code: HRX
• UDI-Device Identifier: 10886705028092
• UDI-Public: 10886705028092
• Combination Product (Y/N): N
• PMA/510(K) Number: K080560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 242047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 06/21/2019
• Patient Sequence Number: 1